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Germ-Line Mutations in Blood and Saliva Samples From Patients With Cancer

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ClinicalTrials.gov Identifier: NCT02280161
Recruitment Status : Recruiting
First Posted : October 31, 2014
Last Update Posted : September 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
This research trial studies germ-line mutations in blood and saliva samples from patients with cancer. Studying samples of blood and saliva from patients with cancer in the laboratory may help doctors learn more about how inherited genetic mutations can affect cancer predisposition (an inherited increase in the risk of developing cancer), their impact on treatment response, and their role in cancer development.

Condition or disease Intervention/treatment
Malignant Neoplasm Other: cytology specimen collection procedure

Detailed Description:

PRIMARY OBJECTIVES:

I. To collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition.

II. To investigate the role of germ-line mutations in predicting cancer outcome and response to therapy.

SECONDARY OBJECTIVES:

I. To determine the effect of the identified variants on tumor micro-ribonucleic acid (miRNA), protein and gene expression.

II. To study expression of DNA, ribonucleic acid (RNA) or protein in the blood of cancer patients with and without variants of interest to discover correlations between such levels and the presence of cancer and/or response to therapy in these patients.

OUTLINE:

Patients undergo collection of blood and saliva samples 1-3 times at the discretion of the investigator for germ-line mutation analysis.

After completion of study, patients are followed up for 5 years.


Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Investigation of the Role of Germ-Line Mutations in Cancer Predisposition, Tumor Biology, and Response to Treatment
Actual Study Start Date : September 16, 2014
Estimated Primary Completion Date : September 16, 2024
Estimated Study Completion Date : September 16, 2025

Group/Cohort Intervention/treatment
Ancillary-Correlative (germ-line mutation analysis)
Patients undergo collection of blood and saliva samples 1-3 times at the discretion of the investigator for germ-line mutation analysis.
Other: cytology specimen collection procedure
Correlative studies
Other Name: cytologic sampling




Primary Outcome Measures :
  1. Prevalence of germ-line variants [ Time Frame: Up to 5 years ]
    The prevalence of germ-line variants of interest will be compared to the baseline prevalence found using available large human genomic DNA collections. The primary statistical analysis will involve comparisons of genotypes between with (cases) and without (controls) the germ-line mutation. This analysis will include Pearson's chi-square analysis or Fisher's exact test and computation of odds ratios to assess the relationship of the genetic polymorphism and cancer risk.

  2. Overall genotype frequencies [ Time Frame: Up to 5 years ]
    The overall genotype frequencies among the cases and expected control levels will first be compared with the frequencies expected from Hardy-Weinberg equilibrium by goodness-of-fit chi-square. Odds ratios and 95% confidence intervals will be used to estimate risk associated with the variant genotypes by using both univariate and unconditional multivariate logistic regression models.

  3. Response to treatment [ Time Frame: Up to 5 years ]
    The impact of inherited variants on response to treatment will be determined.

  4. Cancer development [ Time Frame: Up to 5 years ]
    The role of inherited variants in clinical and pathological cancer development will be determined.


Biospecimen Retention:   Samples With DNA
A blood sample of 30mL or a saliva collection (obtained by spitting into a special collection cup) will be obtained from each patient.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with a confirmed diagnosis of cancer.
Criteria

Inclusion Criteria:

  • Pathologically or clinical confirmed tissue diagnosis of a cancer
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Patients will be excluded if their cancer cannot be confirmed
  • Refusal to sign the informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280161


Locations
United States, California
Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Joanne B. Weidhaas    310-825-9775    jweidhaas@mednet.ucla.edu   
Principal Investigator: Joanne B. Weidhaas         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Joanne Weidhaas Jonsson Comprehensive Cancer Center

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02280161     History of Changes
Other Study ID Numbers: 14-001115
NCI-2014-02065 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB00000173
JCCCID488
14-001115 ( Other Identifier: Jonsson Comprehensive Cancer Center )
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Neoplasms